Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EDI Novel Coronavirus COVID-19 IgG ELISA Kit Recalled by Epitope Diagnostics, Inc. Due to The use of deionized water rather than distilled...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Epitope Diagnostics, Inc. directly.
Affected Products
EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032 Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an aid for the detection of novel COVID-19. Patients with suspected clustering cases require diagnosis or differential diagnosis of novel coronavirus infection.
Quantity: 2886
Why Was This Recalled?
The use of deionized water rather than distilled water during the manufacturing process, may have resulted in accelerated decreased OD signals for the Positive Control value.
Where Was This Sold?
This product was distributed to 20 states: CA, CO, FL, HI, IL, MD, MA, MI, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, VA
About Epitope Diagnostics, Inc.
Epitope Diagnostics, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report